1 PROJECT SUMMARY 2 This application for a Phase II SBIR award extends the successful completion of Phase I and represents a 3 collaboration between Clinitech, LLC and McLean Hospital/Harvard Medical School to continue the 4 development of a wearable biosensor for detecting alcohol in the interstitial fluid of humans. Excessive use of 5 alcohol accounts for much of the public health burden related to alcohol use disorders, including fetal alcohol 6 syndrome, fatal motor crashes, accidents and homicides. On college campuses alone, alcohol use results 7 annually in almost 2,000 deaths, 100,000 sexual assaults, 600,000 injuries, and 700,000 assaults. These 8 figures justify the need at many levels to have a wearable device that can help track individual?s alcohol 9 consumption in real time. A prototype device was developed, and human subject testing proved that it matched 10 very well with blood alcohol concentrations, thus providing a valuable proof-of-concept. The current proposal is 11 aimed at refining the design into a wearable patch and implementing a Commercialization Plan. All patents and 12 licenses are in place at Clinitech and the McLean Hospital team has decades of experience in administering 13 alcohol to human volunteers and then measuring blood, breath and tissue alcohol concentrations. Thus, the 14 two sites are ideal to collaborate on this joint venture and are well poised to continue this project at a very rapid 15 pace. LabPatch-alcohol utilizes novel nanosensor technology that samples interstitial fluid (ISF) from just 16 underneath the skin and then uses an electrochemical reaction to measure alcohol concentration in a few 17 seconds. ISF is superior to breath and sweat-based devices currently on the market as it parallels blood. The 18 device is unobtrusive, will look like an adhesive bandage, causes no injury and will be programmable. The 19 initial prototype was wired to a computer and now we are ready to switch to automated fabrication of an 20 optimal array of sensors and convert the device to a wireless patch that communicates with a Smart-phone. 21 We have identified three fundamental markets: the private sector, AUD Treatment population, and research 22 and have projected price points and market penetrations that will result in a significant positive impact on 23 human health and well-being, while also proving to be a successful commercial endeavor. The research plan 24 will use the same iterative approach by which Clinitech will provide patches to McLean for human testing. 25 Parallel samples of ISF and blood will be tested for alcohol concentration after drinking in order to correlate the 26 pharmacokinetic profile of alcohol in these two compartments. Key milestones for Phase II include: enhance 27 and miniaturize the prototype, develop wireless capabilities, test for sex- and skin-related differences in 28 performance, test for the effects of exercise, and implement a comprehensive Commercialization Plan.